Actively Recruiting
Study of Epcoritamab as a Consolidation Therapy in CLL/SLL
Led by Zulfa Omer · Updated on 2026-01-06
22
Participants Needed
1
Research Sites
201 weeks
Total Duration
On this page
Sponsors
Z
Zulfa Omer
Lead Sponsor
G
Genmab
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase 2 study of Epcoritamab as a consolidation therapy for 2nd generation BTKi +/- Obinutuzumab in CLL/SLL patients or patients with variants of this.
CONDITIONS
Official Title
Study of Epcoritamab as a Consolidation Therapy in CLL/SLL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of CLL or SLL or a variant meeting 2018 iwCLL criteria
- Received second-generation BTKi (acalabrutinib or zanubrutinib) with or without obinutuzumab for at least 12 months as first therapy
- Achieved partial response or better with second-generation BTKi but still have detectable disease by NGS ClonoSEQ
- Age 18 years or older
- ECOG performance status 0 to 2 (or Karnofsky 60% or higher)
- Adequate organ and marrow function as specified (neutrophils, hemoglobin, platelets, bilirubin, liver enzymes, kidney function)
- Women of childbearing potential and non-sterile males must use effective birth control during and 4 months after study
- Women of childbearing potential must have negative pregnancy test within 7 days before study drug
- Non-sterile males must avoid sperm donation during and 4 months after study
- Ability and willingness to provide informed consent
You will not qualify if you...
- Achieved complete remission or nodal partial response with no detectable disease after prior BTKi treatment
- Absence of CD20 on CLL cells before treatment
- Prior treatment with any CD3xCD20 bispecific antibody
- Organ transplant recipients with active graft versus host disease requiring treatment within 12 months
- Received live vaccine within 28 days before starting study treatment
- Autoimmune diseases requiring high dose immunosuppressives (above 20 mg prednisone daily)
- Central nervous system disease unless investigator permits
- Known allergy to study drug components
- Active Richter's transformation (except accelerated phase or prolymphocytic progression)
- Prior radiation therapy impacting ability to participate
- Need for warfarin or equivalent anticoagulant
- Major surgery within 14 days before study drug
- Significant heart disease or recent myocardial infarction
- Pregnant, planning pregnancy, or breastfeeding
- Active infections or uncontrolled medical conditions as defined
- Prior or concurrent malignancy that may interfere with study safety or efficacy assessment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Actively Recruiting
Research Team
U
UCCC Clinical Trials Office
CONTACT
Z
Zulfa Omer, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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